Operations Regulatory CMC Specialist, AstraZeneca

On behalf of our client, AstraZeneca, QRIOS are now looking for a candidate that has previously experience within regulatory affairs, quality assurance or R&D for a consultant assignment with the start in October. Selections and interviews are held on an ongoing basis, please submit your application as soon as possible

About the position
CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca’s global supply chain.
We are looking for a CMC Regulatory Affairs Manager to join our CMC team in Södertälje to support post-approval CMC variations across the globe.

We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other AstraZeneca teams.

Responsibilities

As a CMC Regulatory Affairs Manager you will provide CMC regulatory and compliance advice on regulatory post-approval submissions and project manage timely submissions of post approval CMC documentation.

Our new colleague is expected to have broad knowledge of medicinal products, project management, pharmaceutical process engineering, complex Supply Chains in global organizations, and how you contribute to achieving the objectives of the business as well as an understanding of the teams and organization you interact with. The role offers you opportunities to work with global networks.
You will be encouraged to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance within AstraZeneca.

Vem är du?
You hold a degree in a scientific field (for example, Chemistry, Pharmacy or Chemical Engineering).

In addition, you need:
• Experience from CMC Regulatory affairs or Regulatory affairs
• Experience from working in the Pharmaceutical industry, preferably Pharmaceutical Production, Process Engineering, Quality Assurance or R&D, or experience from Pharmaceutical Agencies or Associations
• Practice from working with or contributing to Regulatory CMC submissions for medical products
• Project management experience, preferably within CMC Regulatory Affairs
• To be proficient in both spoken and written English and Swedish

Desirable for the role
• You have excellent communication skills.
• You can build constructive networks with colleagues and work collaboratively with customers to achieve optimum outcomes for the business.
• Strong project management skills and experience of working within a global environment will be invaluable for planning and controlling your own workload as well as effectively managing the expectations of diverse stakeholders.
• You are comfortable with the use of electronic information and document management tools


About the organisation
QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

About Astra Zeneca:
AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world’s leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.